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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525217-31-00 | Registry Identifier | EU CT Number |
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This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a: Dose Escalation | Experimental | INCA036978 will be administered at a protocol defined starting regimen as monotherapy to identify the MTD and/or RDE(s). |
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| Part 1b: Dose Escalation | Experimental | INCA036978 will be administered at a protocol defined starting regimen in combination with a standard disease-directed therapy to identify the MTD and/or RDE(s). |
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| Part 2a: Dose Expansion | Experimental | INCA036978 will be administered as monotherapy at the RDE(s) identified during Part 1 |
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| Part 2b: Dose Expansion | Experimental | INCA036978 will be administered in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCA036978 | Drug | INCA036978 will be administered at protocol defined dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Dose Limiting Toxicities (DLT)s in Part 1 | Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol. | Up to 28 days |
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as adverse events AE (either reported for the first time or the worsening of a pre-existing event) occurring after the first dose of study drug and up to 60 days after last dose of study drug or until the start of a new disease-directed therapy, whichever occurs first. | Up to approximately 2 years |
| Number of participants with TEAEs leading to dose modification or discontinuation | Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Parameter: Cmax of INCA036978 | Defined as maximum observed plasma concentration of INCA036978. | Up to approximately 2 years |
| Pharmacokinetics Parameter: Tmax of INCA036978 | Defined as the time to reach the maximum plasma concentration of INCA036978. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama At Birmingham | Not yet recruiting | Birmingham | Alabama | 35233 | United States | |
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| Label | URL |
|---|---|
| Study of INCA036978 in Participants With Myeloproliferative Neoplasms | View source |
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| Standard disease-directed therapy | Drug | A standard disease-directed therapy will be administered according to Prescribing Information/SmPC. |
|
| Up to approximately 2 years |
| Pharmacokinetics Parameter: Cmax,ss of INCA036978 | Defined as the maximum observed plasma concentration at steady state of INCA036978. | Up to approximately 2 years |
| Pharmacokinetics Parameter: Cmin,ss of INCA036978 | Defined as the minimum observed plasma concentration at steady state of INCA036978. | Up to approximately 2 years |
| Pharmacokinetics Parameter: AUC(0-t) of INCA036978 | Defined as the area under the concentration-time curve up to the last measurable concentration of INCA036978. | Up to approximately 2 years |
| Pharmacokinetics Parameter: AUC 0-∞ of INCA036978 | Defined as the area under the concentration-time curve from 0 to infinity of INCA036978. | Up to approximately 2 years |
| Pharmacokinetics Parameter: CL/F of INCA036978 | Defined as the apparent clearance of INCA036978. | Up to approximately 2 years |
| Pharmacokinetics Parameter: Vz/F of INCA036978 | Defined as the apparent volume of distribution of INCA036978. | Up to approximately 2 years |
| Pharmacokinetics Parameter: t1/2 of INCA036978 | Defined as the apparent terminal phase disposition half-life of INCA036978. | Up to approximately 2 years |
| For participants with myelofibrosis (MF): Percentage of participants achieving spleen volume reduction as defined in the protocol | Defined as percentage of participants with a protocol defined spleen volume reduction. | Week 12 and Week 24 |
| For participants with MF and anemia: Anemia Response as defined in the protocol | For non transfusion-dependent (TD) participants: An Hb increase relative to baseline as defined in the protocol if non-TD at baseline. For TD participants: Achieving transfusion independency (TI) as defined in the protocol. | Up to approximately 2 years |
| For participants with polycythemia vera (PV): Peripheral blood count remission as defined by the protocol. | Peripheral blood count remission as defined by the protocol. | Up to approximately 2 years |
| For participants with essential thrombocythemia (ET): Peripheral blood count remission as defined by the protocol. | Peripheral blood count remission as defined by the protocol. | Up to approximately 2 years |
| City of Hope-Lennar Foundation Cancer Center |
| Not yet recruiting |
| Irvine |
| California |
| 92618 |
| United States |
| Usc Norris Comprehensive Cancer Center | Not yet recruiting | Los Angeles | California | 90033 | United States |
| UCLA Medical Hematology & Oncology | Not yet recruiting | Los Angeles | California | 90095 | United States |
| Yale Cancer Center | Not yet recruiting | New Haven | Connecticut | 06510 | United States |
| University of Miami | Not yet recruiting | Miami | Florida | 33136 | United States |
| Moffitt Cancer Center | Not yet recruiting | Tampa | Florida | 33612 | United States |
| Winship Cancer Institute of Emory University | Not yet recruiting | Atlanta | Georgia | 30322 | United States |
| John Hopkins Hospital | Not yet recruiting | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
| Washington University School of Medicine | Not yet recruiting | St Louis | Missouri | 63108 | United States |
| Mount Sinai School of Medicine | Not yet recruiting | New York | New York | 10029 | United States |
| Weill Cornell Medicine | Not yet recruiting | New York | New York | 10065 | United States |
| University of North Carolina At Chapel Hill | Not yet recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Levine Cancer Institute | Not yet recruiting | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy | Not yet recruiting | Durham | North Carolina | 27705 | United States |
| Cleveland Clinic | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Not yet recruiting | Columbus | Ohio | 43210 | United States |
| Tristar Bmt/Tcto | Not yet recruiting | Nashville | Tennessee | 37203 | United States |
| University of Texas M. D. Anderson Cancer Center | Not yet recruiting | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute | Not yet recruiting | Salt Lake City | Utah | 84112 | United States |
| Medical College of Wisconsin | Not yet recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Concord General Repatriation Hospital | Recruiting | Concord | New South Wales | 02139 | Australia |
| Royal North Shore Hospital | Not yet recruiting | St Leonards | New South Wales | 02065 | Australia |
| Icon Cancer Centre | Recruiting | Auchenflower | Queensland | 04066 | Australia |
| Epworth Health Care | Recruiting | East Melbourne | Victoria | 03002 | Australia |
| Linear Clinical Research | Recruiting | Nedlands | Western Australia | 06009 | Australia |
| Centre Hospitalier Universitaire (Chu) de Liege | Not yet recruiting | Liège | 04000 | Belgium |
| AZ DELTA | Not yet recruiting | Roeselare | 08800 | Belgium |
| McGill University Jewish General Hospital | Not yet recruiting | Montreal | Quebec | H3T 1E2 | Canada |
| Institut Bergonie | Not yet recruiting | Bordeaux | 33076 | France |
| Hospital Saint Louis | Not yet recruiting | Paris | 75010 | France |
| Institut Gustave Roussy | Not yet recruiting | Villejuif | 94805 | France |
| University Medical Center Rwth Aachen | Not yet recruiting | Aachen | D-52074 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Not yet recruiting | Berlin | 10117 | Germany |
| Universitatklinikum Freiburg | Not yet recruiting | Freiburg im Breisgau | 79106 | Germany |
| Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii | Not yet recruiting | Mainz | 55131 | Germany |
| Aou Policlinico S. Orsola-Malpighi | Not yet recruiting | Bologna | 40138 | Italy |
| Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico | Not yet recruiting | Milan | 20122 | Italy |
| A. Gemelli University Hospital, Catholic University of the Sacred Heart | Not yet recruiting | Roma | 00168 | Italy |
| Azienda Sanitaria Universitaria Friuli Centrale Asu Fc | Not yet recruiting | Udine | 33100 | Italy |
| National Cancer Center Hospital East | Not yet recruiting | Kashiwa Chiba | 277-0882 | Japan |
| Ehime University Hospital | Not yet recruiting | Toon, Ehime | 791-0204 | Japan |
| Hospital Universitari Germans Trias I Pujol | Not yet recruiting | Badalona | 08916 | Spain |
| Hospital Universitario de Gran Canaria Dr. Negrin | Not yet recruiting | Las Palmas de Gran Canaria | 35010 | Spain |
| Hospital Universitario 12 de Octubre | Not yet recruiting | Madrid | 28041 | Spain |
| Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust | Not yet recruiting | London | SE1 9RT | United Kingdom |
| Nottingham University Hospitals | Not yet recruiting | Nottingham | NG5 1PB | United Kingdom |
| University of Oxford | Not yet recruiting | Oxford | OX3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D055728 | Primary Myelofibrosis |
| D013920 | Thrombocythemia, Essential |
| D011087 | Polycythemia Vera |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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